Guiding Aging Long-Term Opioid Therapy Users Into Safer Use Patterns

Sponsor
University of Southern California (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05808127
Collaborator
Northwestern University (Other), National Institute on Aging (NIA) (NIH), University of Washington (Other)
300
2
9

Study Details

Study Description

Brief Summary

Patients on long-term opioid therapy are aging and now face magnified risk of harm with continued high-dose opioid use. These increased risks are due to age-related changes in drug metabolism, multi-morbidity, and polypharmacy. The dominant approach to mitigate these risks is to screen for aberrant patient opioid behaviors so that clinicians can pre-empt misuse early through review of contractual opioid agreements or by lowering patient dosages. By focusing on opioid misuse alone, this strategy encourages forced opioid tapering that is associated with opioid overdose and mental health crisis. Directing clinician attention to the comorbid conditions associated with opioid misuse may promote safer and more effective care.

The objective of this study is to assess the comparative effectiveness of PainTracker, a set of questions that targets a broad range of problems associated with pain, in a randomized controlled trial involving 300 Northwestern Medicine clinicians treating Chronic Opioid Use Registry patients (n=5159).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PainTracker
N/A

Detailed Description

Using the electronic health record, patient portal, and patient-reported outcome capabilities, the investigators will develop programming logic for a randomized experimentation platform wherein two or more versions of pain surveys may be delivered to patients. This system will be used to evaluate PainTracker, delivered to half of the sample (approximately 2,579 patients). Clinicians treating Chronic Opioid Use Registry patients that meet the inclusion criteria will be assigned to one of two conditions involving patient surveys: 1) Current Opioid Misuse Measure [COMM] [standard clinical care] or 2) COMM + PainTracker. Surveys will be delivered monthly and patients will be prompted 3 times to complete the survey; once completed, patients will receive a score also delivered to their physician's inbox in Epic.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Clinicians treating Chronic Opioid Use Registry patients will be randomized to one of two conditions involving surveys completed by the patients: (1) Current Opioid Misuse Measure [COMM] [standard clinical care] or (2) COMM + PainTrackerClinicians treating Chronic Opioid Use Registry patients will be randomized to one of two conditions involving surveys completed by the patients: (1) Current Opioid Misuse Measure [COMM] [standard clinical care] or (2) COMM + PainTracker
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Guiding Aging Long-Term Opioid Therapy Users Into Safer Use Patterns
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Current Opioid Misuse Measure (COMM)

On a monthly basis, patients will receive the abbreviated Current Opioid Misuse Measure (COMM), a 6-item self-report screener to identify and monitor the risk of aberrant opioid-related behavior in chronic pain patients on opioid therapy. The COMM asks patients to report their behaviors over the past 30 days using a five-point Likert-type rating scale.

Experimental: Current Opioid Misuse Measure (COMM) + PainTracker

On a monthly basis, patients will receive both the abbreviated Current Opioid Misuse Measure (COMM) and PainTracker. PainTracker tracks multiple outcomes relevant to the treatment of chronic pain: pain severity, general activity interference, enjoyment of life interference, sleep (initiating and maintaining), depression, and anxiety.

Behavioral: PainTracker
The PainTracker tool reframes the patient visit around improving functional status and obtaining functional goals, understanding psychological concerns that may exacerbate pain such as traumatic stress, anxiety, and depression. This approach may promote an increase in referrals for physical therapy, mental health counseling, and psychiatric follow-up.

Outcome Measures

Primary Outcome Measures

  1. Referral rate to non-opioid care [9 months]

    Patient referral rate to non-opioid care that includes mental and behavioral health care, physical therapy, or sleep medicine referrals

  2. Antidepressant orders [9 months]

    Rate of orders for antidepressant medications

Secondary Outcome Measures

  1. Clinician monthly milligram morphine equivalent (MME) [9 months]

    Clinician aggregate monthly milligram (mg) morphine equivalent (ME) for >50 mg ME daily dose visits

  2. Benzodiazepine prescribing [9 months]

    Clinician aggregate monthly milligram (mg) valium equivalent (VE) for >50 mg VE daily dose visits

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

• Patients age 65 or older on long-term opioid therapy within the Northwestern Medicine Chronic Opioid Use registry system with at least one primary care encounter in the past 12 months.

Exclusion criteria:

• Patient visits with active cancer diagnoses

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Southern California
  • Northwestern University
  • National Institute on Aging (NIA)
  • University of Washington

Investigators

  • Principal Investigator: Jason Doctor, PhD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jason Doctor, Professor, University of Southern California
ClinicalTrials.gov Identifier:
NCT05808127
Other Study ID Numbers:
  • HS-22-00517
  • 3P30AG024968-20S1
First Posted:
Apr 11, 2023
Last Update Posted:
Apr 13, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 13, 2023